As per the National Statement on Ethical Conduct in Human Research (2007 incorporating all updates), ‘institutions are responsible for establishing procedures for the ethical review of human research. That review can be undertaken at various levels, according to the degree of risk involved in the research (see Section 2: Themes in Research Ethics: Risk and Benefit, Consent responsibilities, and Chapter 5.2: Responsibilities of HRECs, other ethical review bodies, and researchers).

Research with more than a low level of risk (as defined in paragraph 2.1.6) must be reviewed by an HREC. Research involving no more than low risk may be reviewed under other processes described in paragraphs 5.1.18 to 5.1.21. Institutions may also determine that some human research is exempt from ethical review (see paragraphs 5.1.22 and 5.1.23).’

A judgment that a human research proposal meets the requirements of this National Statement and is ethically acceptable must be made before research can begin.

To access eProtocol and start your submission process you will need a user name and password. In order to obtain these please go to the eProtocol login page https://eprotocol.bellberry.com.au/ and click on Register.

If you are registering for multiple organisations, you will need to register with a different User ID each time. We suggest using your surname and the PI or site name (e.g Smith-Matthews). Please do not use acronyms in the organisation field on the registration form. Please put the organisation name that you need to be linked to in full. The address that you enter here will appear on all correspondence from Bellberry.

If you are a new organisation to Bellberry please email Bellberry@bellberry.com.au with the details of your organisation, including full address, phone number and ABN number before commencing your registration.

For further assistance with your registration please view the ‘How to Register’ video tutorial below.

Complete and submit the registration form. Your application will be validated and an automated email from bbl@bellberry.com.au with your temporary access details will be emailed to you. When you log on to the system for the first time, you will be asked to change your password.

Passwords will need to be a minimum of 8 characters with 3 or 4 of the following:

Any study documents that are submitted in an application as a PDF should be in a searchable format (i.e not a scanned document). It is important that all documents are appropriately named using a footer to ensure the description reflects the contents (i.e. Protocol No, version no, date). Please refer to our Version Control document for further guidance.

It is very important to NAME and save these documents exactly as you would like them to appear in the approval letter.

All documents that form part of your application must be attached to the application via the eProtocol system (page 7 of the eProtocol application form).

Click here for a comprehensive list of documents that must be submitted for a clinical trial.

Non-Clinical Studies

The application process for non-clinical studies is exactly the same as for clinical studies. You will need to register for eProtocol, complete and submit an application form. However the documents required to be submitted for a non-clinical study may vary. Please click here for a list of documents to be submitted for a non-clinical study.

Multi Centre Applications for Single Review

If you are submitting a multi-centre application, each site is required to submit their own seperate application in eProtocol. The lead site needs to list all Investigators and locations on the eProtocol application form in the Study Sites section. Please follow the instructions on the Application Form.

Optional studies

If it is intended to seek permission for use of optional tissue samples (either residue from obligatory tests or fresh tissue sought), a separate Participant Information Sheet and Consent Form must be included for this secondary purpose.

Log into the eProtocol system. If you have existing studies approved by Bellberry and have not yet lodged a new application via eProtocol, please contact bellberry@bellberry.com.au as an eProtocol User Name has already been created for you. You will not need to register again.

Bellberry hold 2 Committee meetings a week on a Wednesday evening. All study documentation must be submitted via eProtocol 2 weeks prior to a meeting. We are able to hold extra meetings if and when required. Please contact Bellberry prior to submitting your documents if you have specific time frames.

You will receive an automated email from eProtocol to confirm that your application has been received. If your application is incomplete, it will be returned to you with Return Notes detailing what section needs additional information/completion. You will receive notification emails from eProtocol throughout the review process each time an action occurs, so you will receive notification once your study has been allocated to a HREC Committee.

Log on to eProtocol at any time to track your submission by checking your homepage.

An investigator can expect to receive comments detailing the Committee’s deliberations 2 days following the committee meeting the Friday following the Wednesday night Committee meeting. Any questions raised by the committee will require satisfactory responses prior to ethics approval being granted. Please click here for guidance on how to respond to the HREC comments. Please respond promptly to any comments via the eProtocol system to ensure quick turnaround.

Researchers may be invited by the Committee to attend review meetings to present their study or answer questions concerning specific issues either in person or via telephone.

If a response is not received from investigator after six months, they will be issued a reminder. If no response to the reminder is received, Bellberry will then close the study.

Once the Committee is satisfied that all requirements have been met, notification will be sent via eProtocol and the approval letter will be available in the eProtocol system. If the Committee has not approved a study a study rejection letter will be issued by email.

The following resources can assist you with your application preparation and submission:

FAQs

If the lead site has yet to be approved please submit your site application via eProtocol, however you do not need to attach any study documentation on page 7 of your application. If your lead site has already received HREC approval you will need to submit a full application including all your site’s study documentation on page 7.